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Trial record 9 of 26 for:    gi dynamics

An Open-Label Extension to Protocol 09-1, Efficacy and Safety Study of the EndoBarrier® Gastrointestinal Liner System (OLE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by GI Dynamics
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT02293720
First received: November 11, 2014
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

A multi-center, single-arm, open-label study to evaluate the safety and effectiveness of the EndoBarrier Gastrointestinal Liner System liner on glycemic control in control subjects from study #09-1 who are not treatment failures and have completed 12 months of the study.


Condition Intervention
Type 2 Diabetes
Device: EndoBarrier

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension to Protocol 09-1, Multi-Center, Efficacy and Safety Study of the EndoBarrier® Gastrointestinal Liner System for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects

Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • Mean change in HbA1c value from baseline to 12 months [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Changes in HbA1c from baseline to 12 month

  • Measure the incidence of device related serious adverse events requiring an early removal [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Demonstrated to be less than or equal to 15%


Estimated Enrollment: 167
Study Start Date: January 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EndoBarrier Device
Subjects who participated in the control arm of study #09-1 who are not treatment failures and have completed 12 months of the study. These subjects will have the EndoBarrier device implanted for 12 months.
Device: EndoBarrier
The EndoBarrier is indicated as an adjunct to diet and exercise to achieve weight loss and improve glycemic control in obese adults with type 2 diabetes whose anti-diabetes medications have not achieved adequate glycemic control.

Detailed Description:

This is an open-label extension study for subjects who participated in the control arm of study #09-1 (A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents) who are not treatment failures and completed 12 months of the study.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Control subjects from study # 09-1 who are not treatment failures and have completed 12 months of the study
  2. Age ≥21 years and ≤ 65 years
  3. Have signed an informed consent form within 30 days of week 52 visit in study #09-1.
  4. HbA1c ≥ 7.5% and ≤ 10%
  5. Stable (s) doses (up to 2) of anti -diabetes medication(s) for a minimum of 3 months prior to enrollment with at least one at minimum required dose as outlined below:

    1. MET (≥1500 mg/day) OR
    2. SU (based on doses specified below) Generic Name (brand name) minimum required dose

      Glimepiride (Amaryl) 4 (mg/day) Glipizide (Glucotrol) 20 (mg/day) Glipizide (Glucotrol XL) 10 (mg/day) Glyburide (Micronas, Diabeta) 10 (mg/day) Micronized Glyburide (Glynase) 6 (mg/day) Chlorpropamide (Diabinese) 350 (mg/day) Tolazamide (Tolinase 500 (mg/day) Tolbutamide (Orinase) 1500 (mg/day) OR

    3. DPP-4i (based on doses specified below) Generic Name (brand name) minimum required dose Sitagliptin (Januvia®) 50 (mg/day) Saxagliptin (Onglyza®) 2.5 (mg/day) Linagliptin (Tradjenta ®) 5 (mg/day) Alogliptin (Nesina®) 12.5 (mg/day)
    4. TZD (based on doses specified below) Generic Name (brand name) minimum required dose Rosiglitazone (Avandia®) 4 (mg/day) Pioglitazone (Actos®) 30 (mg/day)
  6. BMI ≥ 30 and ≤ 55
  7. Willing to comply with study requirements
  8. Documented negative pregnancy test in women of childbearing potential
  9. Women of childbearing potential not intending to become pregnant for the duration of their trial participation

Exclusion Criteria

  1. Any change from the subject's previous health status from assessment for eligibility in pivotal trial phase (such as a new condition or major illness) that places the subject at undue risk by participating in the study
  2. C-peptide < 1.0 ng/mL
  3. Triglyceride level > 400 mg/dL
  4. Vitamin D deficiency (<20ng/ml)
  5. Male subjects with serum Cr >1.5 mg/dl or female subjects with Cr >1.4 mg/dl
  6. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
  7. Symptomatic kidney stones or gallstones within 6 months prior to baseline (within 30 days of week 52 visit from #09-1 study)
  8. Acute pancreatitis at the time of baseline (within 30 days of week 52 visit from #09-1 study)
  9. Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
  10. Currently taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (e.g. aspirin, ibuprofen, etc.) within 10 days of the procedure and/or there is a need or expected need to use during the trial 12 months post index procedure
  11. Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to the procedure and/or there is a need or expected need to use during the trial 12 months post index procedure
  12. Currently taking the following medications (at the time of enrollment) and/or there is a need or expected need to use these medications during the trial 12 months post index procedure:

    Restricted Medications/Supplements Systemic corticosteroids Drugs known to affect GI motility (e.g. Reglan) Prescription or over-the-counter weight loss medication(s) Medications known to cause significant weight gain (refer to study reference manual (SRM) or weight loss (e.g. chemotherapeutics)

  13. Currently taking ≥ two of the following medications for type 2 diabetes; MET, SU, DDP-4i and TZD at baseline (within 30 days of week 52 visit from #09-1 study)
  14. Currently taking medications for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g. GLP1 or insulin) at baseline (within 30 days of week 52 visit from #09-1 study)
  15. Chronic use of narcotics, opiates, or benzodiazepines and other addictive tranquilizers
  16. Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, and all equivalent antibiotics
  17. Active H. pylori (Note: Subjects may be eligible after undergoing 2 weeks of antibiotic treatment without re-screening)
  18. Residing in a location without ready access to study site medical resources
  19. Documented weight loss of > 10 pounds anytime during the 3 months prior to enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02293720

Contacts
Contact: Kelly Woessner, MS 781-357-3263 kwoessner@gidynamics.com

Sponsors and Collaborators
GI Dynamics
  More Information

No publications provided

Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT02293720     History of Changes
Other Study ID Numbers: 09-1E
Study First Received: November 11, 2014
Last Updated: November 14, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 27, 2015